Individual generic drug information

ranibizumab

Reference monograph

Part of registered formulation

RANIBIZUMAB

Reference record: Ranibizumab
Source: BNF 80 (2020–2021)
Printed source pages: 1276, 1277
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Ranibizumab only.

Indications And Dose

Neovascular (wet) age-related macular degeneration (specialist use only) | Diabetic macular oedema (specialist use only) | Macular oedema secondary to retinal vein occlusion (specialist use only) | Choroidal neovascularisation (specialist use only) ▶BY INTRAVITREAL INJECTION ▶Adult: Initially 500 micrograms once a month, to be administered into the affected eye, until maximum visual acuity is achieved or there are no signs of disease activity, for continued treatment and subsequent dose intervals—consult product literature, discontinue treatment if no improvement in visual and anatomic outcomes Concomitant treatment of diabetic macular oedema, or macular oedema secondary to branch retinal vein occlusion, with laser photocoagulation (specialist use only) ▶BY INTRAVITREAL INJECTION ▶Adult: 500 micrograms, to be administered at least 30 minutes after laser photocoagulation

Source page 1276

Contra Indications

Ocular or periocular infection. severe intra-ocular inﬂammation. signs of irreversible ischaemic visual function loss in patients with retinal vein occlusion (no information available)

Source page 1276

Cautions

Active systemic infection. diabetic macular oedema due to type 1 diabetes (limited information available). diabetic patients with HbA1c over 12%. history of stroke. history of transient ischaemic attack. patients at risk of retinal pigment epithelial tear. previous intravitreal injections. proliferative diabetic retinopathy. retinal detachment or macular hole (discontinue treatment if rhegmatogenous retinal detachment or stage 3 or 4 macular holes develop). uncontrolled hypertension CAUTIONS, FURTHER INFORMATION Ranibizumab is given by intravitreal injection by specialists. There is a potential risk of arterial thromboembolic events and non-ocular haemorrhage following the intravitreal injection of vascular endothelial growth factor inhibitors. Endophthalmitis can occur after intravitreal injections— patients should be advised to report any signs of infection immediately.

Source page 1276

National Funding Access Decisions

NICE decisions ▶Ranibizumab for treating choroidal neovascularisation associated with pathological myopia (November 2013) NICE TA298 Ranibizumab is recommended as an option for treating visual impairment due to choroidal neovascularisation secondary to pathological myopia when the manufacturer provides ranibizumab with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta298 ▶Ranibizumab for the treating visual impairment caused by macular oedema secondary to retinal vein occlusion (May 2013) NICE TA283 Ranibizumab is recommended as an option for treating visual impairment caused by macular oedema: . following central retinal vein occlusion or . following branch retinal vein occlusion only if treatment with laser photocoagulation has not been beneﬁcial, or when laser photocoagulation is not suitable because of the extent of macular haemorrhage and . only if the manufacturer provides ranibizumab with the discount agreed in the patient access scheme revised in the context of NICE technology appraisal guidance 274. Patients currently receiving ranibizumab whose disease does not meet the criteria listed above should be able to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta283 ▶Ranibizumab for treating diabetic macular oedema (February 2013) NICE TA274 Ranibizumab is recommended as an option for the treatment of visual impairment due to diabetic macular oedema only if: . the eye has a central retinal thickness of 400 micrometres or more at the start of treatment and . the manufacturer provides ranibizumab with the discount agreed in the patient access scheme (as revised in 2012). Patients currently receiving ranibizumab for treating visual impairment due to diabetic macular oedema whose disease does not meet the criteria should be able to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta274 ▶Ranibizumab and pegaptanib for the treatment of age-related macular degeneration (updated May 2012) NICE TA155 Ranibizumab is recommended for the treatment of wet age-related macular degeneration if all of the following apply: . the best corrected visual acuity is between 6/12 and 6/96; . there is no permanent structural damage to the central fovea; . the lesion size is less than or equal to 12 disc areas in greatest linear dimension; . there is evidence of recent presumed disease progression; . the manufacturer provides ranibizumab with the discount agreed in the patient access scheme (as revised in 2012). Ranibizumab should only be continued in patients who maintain adequate response to therapy. www.nice.org.uk/guidance/ta155 Scottish Medicines Consortium (SMC) decisions SMC No. 381/07 The Scottish Medicines Consortium has advised (June 2007) that ranibizumab (Lucentis ®) is accepted for use within NHS Scotland for the treatment of neovascular (wet) age- related macular degeneration. SMC No. 711/11 The Scottish Medicines Consortium has advised (December 2012) that ranibizumab (Lucentis ®) is accepted for restricted use within NHS Scotland for the treatment of visual impairment due to diabetic macular oedema in adults with best corrected visual acuity 75 Early Treatment Diabetic Retinopathy Study letters or less at baseline. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. 732/11 Eye The Scottish Medicines Consortium has advised (May 2013) that ranibizumab (Lucentis ®) is accepted for use within NHS Scotland for the treatment of macular oedema secondary to branch or central retinal vein occlusion in adults. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. 907/13 The Scottish Medicines Consortium has advised (November 2013) that ranibizumab (Lucentis ®) is accepted for use within NHS Scotland for the treatment of visual impairment due to choroidal neovascularisation secondary to pathologic myopia in adults. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. All Wales Medicines Strategy Group (AWMSG) decisions AWMSG No. 3233 The All Wales Medicines Strategy Group has advised (June 2018) that ranibizumab (Lucentis ®) is recommended as an option for use within NHS Wales for the treatment of visual impairment in adults due to choroidal neovascularisation not due to pathological myopia or wet age-related macular degeneration. This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price.

Source page 1277

Safety

Extracted information for Ranibizumab only.

Interactions

→Appendix 1: ranibizumab

Source page 1276

Side Effects

▶Common or very common Anaemia. anxiety. arthralgia. cataract. cough. dry eye. eye discomfort. eye disorders. eye inﬂammation. haemorrhage. headache. hypersensitivity. increased risk of infection. lens opacity. nausea. retinal pigment epithelial tear. vision disorders ▶Uncommon Corneal deposits ▶Frequency not known Arterial thromboembolism

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Conception And Contraception

Manufacturer recommends women use effective contraception during and for at least 3 months after treatment.

Source page 1276

Pregnancy

Manufacturer advises avoid unless potential beneﬁt outweighs risk.

Source page 1276

Breast Feeding

Manufacturer advises avoid—no information available.

Source page 1276

Monitoring Requirements

▶Manufacturer advises monitor intra-ocular pressure, perfusion of the optic nerve head, and for signs of ocular infection following injection. ▶Manufacturer advises monitor visual acuity.

Source page 1277

Dose and formulations

Extracted information for Ranibizumab only.

Directions For Administration

For further information on administration, consult product literature.

Source page 1277

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶Lucentis (Novartis Pharmaceuticals UK Ltd) Ranibizumab 10 mg per 1 ml Lucentis 2.3mg/0.23ml solution for injection vials | 1 vial P £551.00 (Hospital only) Lucentis 1.65mg/0.165ml solution for injection pre-filled syringes | 1 pre-filled disposable injection P £551.00 PHOTOSENSITISERS

Source page 1277

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 500 micrograms once a month, to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1276

Adults

First line only; read the complete Indications and dose section above.

500 micrograms, to be administered at least

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1276

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

ranibizumab

Reference monograph

Part of registered formulation

RANIBIZUMAB

Reference record: Ranibizumab
Source: BNF 80 (2020–2021)
Printed source pages: 1276, 1277
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Ranibizumab only.

Indications And Dose

Source page 1276

Contra Indications

Ocular or periocular infection. severe intra-ocular inﬂammation. signs of irreversible ischaemic visual function loss in patients with retinal vein occlusion (no information available)

Source page 1276

Cautions

Source page 1276

National Funding Access Decisions

Source page 1277

Safety

Extracted information for Ranibizumab only.

Interactions

→Appendix 1: ranibizumab

Source page 1276

Side Effects

Source page 1276

Conception And Contraception

Manufacturer recommends women use effective contraception during and for at least 3 months after treatment.

Source page 1276

Pregnancy

Manufacturer advises avoid unless potential beneﬁt outweighs risk.

Source page 1276

Breast Feeding

Manufacturer advises avoid—no information available.

Source page 1276

Monitoring Requirements

▶Manufacturer advises monitor intra-ocular pressure, perfusion of the optic nerve head, and for signs of ocular infection following injection. ▶Manufacturer advises monitor visual acuity.

Source page 1277

Dose and formulations

Extracted information for Ranibizumab only.

Directions For Administration

For further information on administration, consult product literature.

Source page 1277

Medicinal Forms

Source page 1277

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 500 micrograms once a month, to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1276

Adults

First line only; read the complete Indications and dose section above.

500 micrograms, to be administered at least

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1276

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.